Compliance Training Webinars for Regulated Industries

This 5-hr GMP requirements training for Combination Products will help you understand FDA's draft guidance on GMPs for Combination Products and provide practical solutions and tools for revamping your quality system to meet this new paradigm.

This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.

This webinar on Documentation and Discipline will cover discipline policies, standards of conduct, and the process of counseling and progressive discipline, up to and including terminations. It will also cover legal aspects of discipline and discharge.

This 6-hr webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.

This Software Project Management training is designed to help executives and managers set and deliver on appropriate and realistic expectations, and avoid the 90% Syndrome.

This Software Testing training will review a testing method based on 'Design of Experiments' to greatly reduce redundant test cases and ensure that maximum number of defects are found.

This 90 minute webinar on legal HR documentation will address why documentation is important in every employment decision you make. Learn from real life lessons, from actual court cases, of how documentation helped an employer to win its case and how wrong documentation ensured a loss.

This 3-hr virtual seminar will cover the USFDA's regulation of cell therapies and HCT/Ps, FDA's labeling and promotional rules and the agency's current enforcement activities in the areas of cell and gene therapies, and HCT/Ps generally.

This 3-hr presentation covers specific issues affecting Credit and Accounts Receivable, including Credit Risk Management, the adequacy of provisions for Bad Debt, Collection Procedures, dependence on processes outside the credit department, and outside the company. This seminar will help Credit Professionals understand their responsibilities and duties so that they can be confident that their Credit and Accounts Receivable processes are Sarbanes-Oxley compliant.

This 4-hr virtual seminar will focus on Japan's overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. It will cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in Japan.

This webinar on Telemedicine Programs will focus on critical issues to be addressed before joint program connecting remote and central locations is planned and implemented. New technical and regulatory developments like that of FDA on Medical Data Device Systems (MDDS) and its implications on the telehealth community will be discussed.

This webinar on OFCCP Compliant Compensation Programs will focus on what to expect from the OFCCP with regard to your Pay Programs, recent enforcement initiatives and principles of establishing an equitable pay system.

This webinar will identify components of a valid letter of guarantee for the food processor and the determinations that food packaging supplier must make in issuing the guarantee, certifying that they comply with US FDA regulations.

This 4 hour training will focus on best practices in design reviews and show how you can add high value to your products and processes by improving the performance while reducing the life cycle costs significantly.

This webinar on Hazard Recognition Techniques will help increase your awareness of workplace hazards, provide meaningful and useful hazard identification procedures, methods to perform 'hazard' surveys that reduce risks that can lead to worker exposures to hazardous materials or injuries.

This FDA Pre-Approval Inspection training will focus on the purpose and scope of pre-approval inspections, the consequences from them, and keys to a successful FDA pre-approval inspection.

This webinar on Wellness Programs will show you how to distinguish between real and fabricated wellness reports by identifying phony metrics, and choose a wellness program that best fits your organization.

This full day GCP training course will provide comprehensive learning on the Good Clinical Practices of Research involving human subjects. It will cover all key areas including recruiting study subjects, the Informed Consent process, Adverse Event Reporting and preventing protocol deviations.

This webinar addresses new test methods for quantifying migration of Printing inks on food packaging materials into the packaged food and how they affect food safety law compliance.

This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Japan, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.